Fosfomycin trometamol — Granules for oral solution

المنتج المرجعي للتكافؤ الحيوي · Fosfomycin trometamol

MoleculeFosfomycin trometamol
Dosage formGranules for oral solution
Reference comparatorMonurol / Monuril (Zambon)
TierA
Recommended BE approachQ1/Q2 sameness + physicochemical / pharmacopoeial equivalence; PK if warranted
NoteSachet — Q1/Q2 sameness
Illustrative harmonised register entry for the Arab markets. Confirm the definitive comparator with the authority of each market before use.
سجل استرشادي موحد · يلزم تأكيد المقارن النهائي من سلطة كل سوق قبل الاستخدام.

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Cite as: AUPAM Experts' Office, Fosfomycin trometamol (Granules for oral solution) — bioequivalence reference product — AUPAM Register, retrieved 2026-08-31, https://aupameo.org/datasets/register/fosfomycin-trometamol-s198.html